Efficacy Study II on Remote Ischemic Conditioning for the Prevention of Stroke-Associated Pneumonia

NCT05982015 | Completed DMC

• 1 other identifier: RICA-2
• Study Type: interventional
• Target: 1,651
• Locations: 1 country
• Sites: 1

Brief Summary

Verifying whether remote ischemic adaptation can reduce the occurrence of stroke related pneumonia in acute stroke patients within 24 hours of onset

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Stroke-associated pneumonia

  Stroke-associated pneumonia incidence rate

  7 days

Secondary Outcomes (12)

• Physician diagnosed pneumonia

  7 days

• Physician diagnosed pneumonia

  8-90 days

• Modified Rankin scale score from 0 to 1

  90 days after the onset of symptoms

• Modified Rankin scale score from 0 to 2

  90 days

• Modified Rankin scale scores

  90 days

Other Outcomes (5)

• Spots of skin bleeding within 7 days

  7 days

• Red or swollen arms within 7 days

  7 days

• Dizziness within 7 days

  7 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Remote ischemic conditioning (RIC) -200mmHg and best medical management

Device: Remote ischemic conditioning

Sham group

SHAM COMPARATOR

Remote ischemic conditioning (RIC) -60mmHg and best medical management

Device: Sham remote ischemic conditioning

Interventions

Remote ischemic conditioning DEVICE

The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.

Intervention group

Sham remote ischemic conditioning DEVICE

The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 60 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.

Sham group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 years old;
• Diagnosis of acute ischemic stroke;
• Remote ischemic conditioning or sham-remote ischemic conditioning can be treated within 24 hours after stroke onset
• NIHSS score≥4;
• Subject or his or her legally authorized representative was able to provide informed consent.

You may not qualify if:

• During the screening period, body temperature ≥ 38 ℃;
• Evidence of lung infection, urinary tract infection or other infectious diseases during the screening period
• Expected lifespan less than 7 days
• Mechanical ventilation is expected to be required within 7 days;
• Anti-infective drug were used within 7 days prior to stroke;
• Uncontrolled hypertension with medication (defined as systolic blood pressure ≥200 mmHg and/or diastolic blood pressure ≥110 mmHg);
• There are contraindications for remote ischemic conditioning (such as skin and soft tissue injury, fractures, peripheral arterial disease, etc. in the upper limbs);
• History of autoimmune disease or malignancies;
• Use of immunosuppressive drug within the preceding 3 months;
• Pregnant or lactating, or pregnancy test positive;
• Current participation in another investigational trial;
• Other conditions are not suitable for this trial as evaluated by researchers.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

Related Publications (8)

• Westendorp WF, Vermeij JD, Zock E, Hooijenga IJ, Kruyt ND, Bosboom HJ, Kwa VI, Weisfelt M, Remmers MJ, ten Houten R, Schreuder AH, Vermeer SE, van Dijk EJ, Dippel DW, Dijkgraaf MG, Spanjaard L, Vermeulen M, van der Poll T, Prins JM, Vermeij FH, Roos YB, Kleyweg RP, Kerkhoff H, Brouwer MC, Zwinderman AH, van de Beek D, Nederkoorn PJ; PASS investigators. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial. Lancet. 2015 Apr 18;385(9977):1519-26. doi: 10.1016/S0140-6736(14)62456-9. Epub 2015 Jan 20.

  PMID: 25612858 BACKGROUND

• Kalra L, Irshad S, Hodsoll J, Simpson M, Gulliford M, Smithard D, Patel A, Rebollo-Mesa I; STROKE-INF Investigators. Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial. Lancet. 2015 Nov 7;386(10006):1835-44. doi: 10.1016/S0140-6736(15)00126-9. Epub 2015 Sep 3.

  PMID: 26343840 BACKGROUND

• Hoffmann S, Harms H, Ulm L, Nabavi DG, Mackert BM, Schmehl I, Jungehulsing GJ, Montaner J, Bustamante A, Hermans M, Hamilton F, Gohler J, Malzahn U, Malsch C, Heuschmann PU, Meisel C, Meisel A; PREDICT Investigators. Stroke-induced immunodepression and dysphagia independently predict stroke-associated pneumonia - The PREDICT study. J Cereb Blood Flow Metab. 2017 Dec;37(12):3671-3682. doi: 10.1177/0271678X16671964. Epub 2016 Oct 14.

  PMID: 27733675 BACKGROUND

• Chamorro A, Meisel A, Planas AM, Urra X, van de Beek D, Veltkamp R. The immunology of acute stroke. Nat Rev Neurol. 2012 Jun 5;8(7):401-10. doi: 10.1038/nrneurol.2012.98.

  PMID: 22664787 BACKGROUND

• Iadecola C, Anrather J. The immunology of stroke: from mechanisms to translation. Nat Med. 2011 Jul 7;17(7):796-808. doi: 10.1038/nm.2399.

  PMID: 21738161 BACKGROUND

• Chamorro A, Urra X, Planas AM. Infection after acute ischemic stroke: a manifestation of brain-induced immunodepression. Stroke. 2007 Mar;38(3):1097-103. doi: 10.1161/01.STR.0000258346.68966.9d. Epub 2007 Jan 25.

  PMID: 17255542 BACKGROUND

• Randhawa PK, Bali A, Jaggi AS. RIPC for multiorgan salvage in clinical settings: evolution of concept, evidences and mechanisms. Eur J Pharmacol. 2015 Jan 5;746:317-32. doi: 10.1016/j.ejphar.2014.08.016. Epub 2014 Aug 28.

  PMID: 25176179 BACKGROUND

• Jia L, Hou C, Mei Q, Zhang B, Zhao W, Zhao H, Shang S, Guo X, Ma Q, Song H, Li C, Meng R, Xu W, Wang Y, Xu G, Wu C, Ji X, Investigators FTR. Remote ischemic conditioning for the prevention of stroke-associated pneumonia (RICA-2): protocol for a multicenter, prospective, randomized, double-blind, sham-controlled phase III trial. Trials. 2025 Oct 16;26(1):419. doi: 10.1186/s13063-025-09140-x.

  PMID: 41102804 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chuanjie Wu, M.D.

  Xuanwu Hospital of Capital Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 8, 2023
• Study Start: January 22, 2024
• Primary Completion: September 19, 2024
• Study Completion: December 19, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

CN (1)